Clinical trial · Observational
Impact of Pre-existing Invasive Aspergillosis on Allogeneic Stem Cell Transplantation
Impact of Pre-existing Invasive Aspergillosis on Allogeneic Hematopoietic Stem Cell Transplantation for Treatment of Acute Leukaemia and Myelodysplastic Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Via a prospective non-interventional study clinical outcome of patients with - and without - history of pre-existing invasive aspergillosis undergoing allo-HSCT will be assessed, in terms of non-relapse mortality overall mortality and fungal infectious morbidity. Aim. Assessment of 1-year outcome of patients undergoing allo-HSCT with history of pre-existing IA vs. no pre-existing IA. Hypothesis. NRM in patients with pre-existing IA is not higher (by a specified margin of 10%) than patients without pre-existing IA. Study population. First allo-HSCT in patients with acute leukaemia and MDS given stem cell grafts. Cohort 1: History of probable or proven invasive aspergillosis Cohort 2: No History of probable or proven invasive aspergillosis: this cohort includes also the patient with a history of possible mycosis not documented microbiologically.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Aspergillosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cases: Prior Invasive Aspergillosis
- description
- History of probable or proven Invasive Aspergillosis according to EORTC 2008 criteria
- label
- Controls: No prior proven Invasive Aspergillosis
- description
- Patients really negative for Invasive Aspergillosis and those with possible Invasive Aspergillosis
Primary outcomes (1)
- measure
- Non-relapse mortality
- timeFrame
- 1 year
- description
- One year non-relapse mortality cumulative incidence
Secondary outcomes (5)
- measure
- Relapse free survival
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * First allo-HSCT * Acute leukaemia or MDS * Received stem cell grafts Exclusion Criteria: * History, in the 6 months preceding HSCT, or documented presence of Invasive candida or mould infections other than IA (Mucor, Fusariosis). * (Previous history Candida infection, both superficial or systemic, is not an exclusion criteria if the patient has completely recovered from it at HSCT).
References
Publications (0)
Data not yet available